The 10 Commandments of clinical project manager

Are you Head of clinical project or CRA coordinator-junior or experienced? The clinical project management is to plan, organize, monitor and control all aspects of a clinical study in order to achieve the objectives within the cost and time. I give you a few ways to have an effective project management.

You will find below the 10 commandments of the clinical project leader.

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1. Clear goals, you shall determine

You shall determine clear goals for your team that is; goals to achieve that are measurable (that is to say encrypted).

2. The study, you shall plan

You shall plan your study and you will distribute this schedule to your team. You will indicate on this schedule:

• The time scale.

You will separate your planning into several periods (e.g., every 3 months) to get a readable document for your team.

• All tasks to be undertaken to advance the project.
• The names of those responsible for these tasks.

Each team member (including the assistant, data manager, statistician…) will see their own responsibilities and those of others (even those of the project manager). The goal will be to have transparency on project management. This will increase the group cohesion and allow everyone to assess the priorities and impact of each of the team members on the project.

• The indicators of study progress

An example of progress indicator:

70% of CRFs monitored, 3 months before the base closure

80% of CRFs monitored, 2 months before the base closure

90% of CRFs monitored, 1 month before the base closure

100% of CRFs monitored, 15 days before the base closure

• The quality controls in place for the project

For example, checking the % CRF monitored every month

This planning will be updated every month and will track and present the project progress during the team meetings.

3. A risk management plan, you shall create

You shall create a risk management plan that will evolve over time. You will integrate all possible risks for your project, their possible impact on your project, the probability of occurrence of these risks, preventive actions that you shall put in place in case these risks and trends arrive at the time of writing the risk management plan. Try to anticipate all risks (e.g. the absence of an employee, failure of a subcontractor, the lack of inclusion…). By completing this work, you will compensate easier to all sorts of problems because you thought about them well before.

4. The proper management style, you shall apply

There are 4 styles of management. No management style is better than another. Management styles are more or less well adapted to an employee in a given situation. You will have to adapt your management style based on your team members, their autonomy and the situations they go through.

The four management styles:

The directive style: Order and organize.

• Your attitude: You are steadfast and you watch the results closely.
• The advantage: This provides an immediate result.
• The risk: Your collaborators can develop the wait-and-see policy and this can demobilize people of good will.

The persuasive style: Explain and convince.

• Your attitude: You listen to opinions and suggestions while taking decisions and explaining them to your team.
• The advantage: This allows binding the team together, giving the motivation for the project
• The risk: This style may still impede the autonomy and the spirit of initiative as you continue to make all decisions.

The participative style: Involve and engage.

• Your attitude: You play the role of referee, you share the decisions and ideas, and you listen and negotiate.
• The advantage: You develop a sense of belonging to the team.
• The Risk: Some employees, who need to be framed, will feel overwhelmed.

The delegative style: Delegate and follow

• Your attitude: You let almost completely the initiative, you valid the proposed solutions, you help punctually and evaluate periodically.
• The advantage: you free yourself of certain tasks; it motivates and increases your collaborator’s experience.
• The risk: you will not know the real difficulties of your collaborator, which can lead to failure.

Sources: Wikipedia, the 4 management styles.

5. Your team, you shall make them responsible and you shall give them autonomy

You must make it clear to your team what you expect and why it is important for them and for you. You can, for example, restate and rephrase to make sure your request has been understood. Indeed, the same sentence will not be understood in the same way between different persons.

You shall make sure that responsibility or mission is well suited to the skills of your colleague. You shall help him in difficulties and you shall make regular checks to ensure that the objectives are achieved.

You must have confidence in your team and you shall not give up if they make mistakes.

You shall praise successes as this is encouraging!

6. At your team, you shall delegate

You will have to choose a collaborator able to accomplish the task to delegate and you will communicate clearly the nature of the task. You will have to insist on the expected result, the importance of the task, and the time to achieve it. The whole team should be informed of the delegated task, of the delegated authority and of the new responsibility for your collaborator in order to give him legitimacy. This will avoid confusion and disputes.

You shall not delegate only uninteresting tasks because you will take the risk of demotivating your team. You will not give too much responsibility at the same time and especially not at the last moment…

7. From quality control, you shall do

You shall absolutely carry out a quality control on your project (not more than 3 to 4 levels of control. For example: inclusions, CRFs, deviations, TMF) and you shall commit on the frequency and content of your control with your team. The results of these tests will be discussed and submitted in written in the monthly team meeting.

You will ask your team to perform a quality control by themselves on their work that they will communicate to you (e.g.: Time spent on site, transmission of monitoring reports).

You will carry out your own quality control by yourself that you will communicate to your team. There will be also a transparency on your work of project manager (example: Respect the schedule of project meetings, Execution of quality controls).

8. Project meetings, you shall organize

Before each meeting, you will send a schedule that you will follow. The meetings should not last more than 1h30 at risk of losing your audience.

During these meetings, you will discuss about specific goals, priorities, organization, potential brakes from team members, or outsiders on the project; and about quality controls executed or to execute.

9. A dashboard, you shall create

The dashboard will communicate, to the team and the supervisor, results regarding project progress. The dashboard should be visual (curve) and always contain the same type of information in order to assess the project’s progress. It will hold in a single page for summarizing key information. They will color it to indicate whether the progress indicator is good or not.

10. The budget, you shall follow

To track your budget, you will use the technical specifications, the quote or contract your project. You will prepare a table of budget progress and you will follow monthly the progress of budget consumption.

The human relationship is an important component of managing a project team. There is of course no secret recipe to manage the human. To succeed at best in the profession of clinical project manager, it is necessary to communicate as much as possible with his team and with external stakeholders to move together in the same direction.